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Small Bone Innovations, Inc. recalls SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with s
Recalled June 11, 2014 · FDA recall Z-1720-2014 · Small Bone Innovations
Hazard
Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside. · FDA Class II
Units
44
Sold at
US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Description
Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.
Product
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
Manufacturer(s)
Small Bone Innovations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →